Category: Regulation

Plain packaging not working
Fifty-nine percent of Australians believe that standardized tobacco packaging has been ineffective, according to a CanvasU poll commissioned by Japan Tobacco International.
JTI said the recent poll had been conducted to provide understanding about Australians’ views on the country’s standardized-tobacco-packaging policy, five years after its implementation.
The research found that while 59 percent of Australians believe that standardized packaging has been ineffective, 80 percent of them believe the government wouldn’t change or would be reluctant to change a preferred policy even if the evidence were weighted against it.
According to a note posted on JTI’s website, even the Australian government’s data justified such public scepticism. The most recent figures from the Australian Institute of Health and Welfare showed that ‘…while smoking rates have been on a long-term downward trend, for the first time in over two decades, the daily smoking rate did not significantly decline over the most recent three-year period (2013 to 2016)’.
“Unsurprisingly, early data from France and the United Kingdom is pointing in the same direction”, Michiel Reerink, JTI’s global regulatory strategy vice president, was quoted as saying.
JTI said that, according to a new report published by Europe Economics, the implementation of the Tobacco Products Directive (TPD2) and the introduction of standardized packaging requirements in the UK and France, had not had any impact on smoking rates or tobacco sales.
Recent data published by the French public authorities confirmed that, after nine months, the level of tobacco-product distribution to retailers had remained stable.
‘Around the world, anti-tobacco activists and some health authorities are calling for similar experimental policies to be rolled-out on other product categories such as alcohol, sugary drinks and fast food, JTI said. ‘In December 2016, Public Health England published a report calling for plain packaging on alcohol, a topic which has been raised again this month by medical journal The Lancet. In Canada, the Ontario Medical Association has mocked up images of plain packaging on food and drink products.’
JTI added that it was therefore no surprise that CanvasU’s research had found that at least half of Australians thought it was likely that standardized packaging would be introduced on alcohol and food & drink with a high sugar content in the future; or that it was already in place.
In fact, a majority of Australians expected this policy to be just the start of an escalation in lifestyle regulation in the future.
“An increasing number of regulators are looking at extreme tobacco-style regulations on other product categories without considering proper evidence or research into the consequences,” said Reerink. “Brand owners should be worried about this domino-effect as policy-makers won’t stop with tobacco.”
November 30, 2017
FDA forming nicotine group
The US Food and Drug Administration says that it is forming a Nicotine Steering Committee to help develop and implement nicotine policy and regulation.
This development is said to be in support of the agency’s comprehensive new tobacco regulatory plan announced in July.
And it is said to be aimed at addressing what the FDA describes as ‘the public health crisis of addiction to tobacco products in this country’.
‘The committee, which will include senior leadership from the Center for Tobacco Products [CTP], Center for Drug Evaluation and Research, and Office of the Commissioner, will focus on nicotine replacement therapies (NRTs), which are designed to help people quit smoking,’ the CTP said in a press note. ‘The committee will examine the evolving science behind the agency’s evaluation of these NRTs, including the types of safety and efficacy studies FDA requires and how these products are used and labeled.
‘As the committee’s first action, it will hold a public hearing for FDA to obtain feedback on public health, scientific, regulatory, and legal considerations relating to NRT products and their use for cessation.’
The hearing is scheduled for January 26 at the FDA’s White Oak Campus in Silver Spring, Maryland. Registration for attending or presenting at the hearing is required by January 2. But electronic or written comments will be accepted after the public hearing until February 15.
More information is available at: https://www.federalregister.gov/documents/2017/11/30/2017-25671/the-food-and-drug-administrations-approach-to-evaluating-nicotine-replacement-therapies-public.
November 30, 2017
Suck it and see
US federal officials considering new regulations on tobacco products should give more weight to the fact that a majority of smokers are unhappy about feeling addicted to cigarettes, and should put less emphasis on the theory that smokers who quit are losing ‘pleasure’ in their lives, according to a recent study by the School of Public Health at Georgia State University (GSU), the US.
Researchers at the school’s Tobacco Center of Regulatory Science (TCORS) analyzed data from 1,284 adult smokers in the US and found more than 80 percent expressed discontent about their inability to quit, felt they were addicted to cigarettes and regretted they started smoking.
A note on the GSU website said the Food and Drug Administration was required to perform an economic cost-benefit analysis of proposed regulations.
‘The agency has included a measure of the “lost pleasure” of smoking in its analysis of regulations on cigarettes, such as proposals to require visually graphic warning labels similar to those required in many other countries,’ the note said.
‘Some researchers have questioned whether smokers enjoy the habit and whether a focus on “lost pleasure” overstates the economic burden on smokers of regulations designed to encourage them to quit and to prevent others from taking up the habit.
‘Results of the study are published in an article titled Reassessing the importance of ‘lost pleasure’ associated with smoking cessation: Implications for social welfare and policy, in the journal Tobacco Control.’
The study is at: http://dx.doi.org/10.1136/tobaccocontrol-2017-053734
November 29, 2017
EU looks at ‘stronger’ rules
The EU Commissioner for Health and Food Safety has indicated that he is exploring the possibility of introducing ‘stronger’ regulations in respect of vapor products, according to a EurActiv.com story relayed by the TMA.
Vytenis Andriukaitis was quoted as saying that he saw the possibility of encouraging “our agents to look into electronic cigarettes, and how to go in the direction of stronger regulation…”.
‘Stronger’ regulation here seems to equate with more restrictive regulation; so, for instance, stopping advertising and online sales of all vapor products.
Andriukaitis pointed out that the tobacco industry was developing new electronic devices, including heat-not-burn devices, that were not covered by existing EU directives.
He said tobacco companies were “already feeling the pressure” from the implementation of the EU’s revised Tobacco Products Directive and were allegedly exploring ways to bypass it and mislead consumers.
Many market “deviations” had been noticed, he added.
November 28, 2017
Let them smoke cigarettes
Indonesia’s Trade Minister has suggested that people who are unable to access vapor products should simply turn – or more likely, turn back – to regular cigarettes, according to a story by Vincent Bevins on washingtonpost.com.
Enggartiasto Lukita apparently issued his advice last week because the authorities are about to place prohibitive restrictions on the sale of electronic-cigarette ‘materials’.
New vapor-product legislation, which is due to go into effect in the next few months, will require vendors to seek a combination of special government licenses, which could take years to acquire.
“These are standards we’ll never be able to meet,” says Rhomedal, a spokesperson for Indonesia’s Personal Vaporizer Association, who, like some Indonesians, uses only one name.
“It will really hurt both small businesses and consumers in our sector.”
A growing number of Indonesians have been using e-cigarettes: people who, according to the minister – as reported by the local newspaper Kompas – can just “become regular smokers”.
Bevins described this as a ‘seemingly puzzling statement for a government official in a country where over 200,000 people already die of tobacco-related causes each year’.
‘But observers of politics in the world’s fourth most populous country say this is nothing new, and that because of the power of the tobacco industry here, Indonesia lags far behind rest of the world in controlling use, and suffers from severe health problems as a result,’ Bevins said.
Indonesia was the only country in the Asia-Pacific region that had not ratified the World Health Organization’s Framework Convention on Tobacco Control, and more than five million children smoked cigarettes, said Dr. Widyastuti Soerojo, head of the Tobacco Control Unit in the Indonesian Public Health Association.
However, this does not explain Indonesia’s puzzling stance on e-cigarettes given that the WHO has also opposed the use of these products; as is reflected in the negative attitudes to e-cigarettes of a number of countries in the Asia-Pacific region.
November 28, 2017
2025 ‘tobacco-free’ goal
Turkmenistan has set a goal of becoming tobacco-free by 2025, Kristina Mauer-Stender, program manager for tobacco control at the World Health Organization’s regional office for Europe, said in an interview reported by AzerNews.
As has become ‘normal’, ‘tobacco-free’ is here defined as the point at which the number of smokers in the country no longer exceeds five percent of the adult population.
“I would like to stress that it is very important for other countries to learn from Turkmenistan’s positive experience,” she said.
Turkmenistan has a leading position in the fight against tobacco smoking. As of April 2016, the country was said to have recorded the lowest smoking rate (8.3 percent) in WHO’s European region.
Turkmenistan ratified the WHO’s Framework Convention on Tobacco Control in 2011.
And it was said to have adopted a national action plan for tobacco control that included raising public awareness, strengthening relevant legislation and regulations, governing the sale of tobacco products to minors, and strengthening co-operation with international organizations.
November 27, 2017
Minimum pricing mooted
Setting a minimum price for tobacco products could be used as part of a campaign to reduce the number of smokers in Scotland, according to a BBC Online story.
The proposal was made after the Scottish government announced it would introduce minimum alcohol pricing from next May.
Public health experts in Scotland are suggesting, too, that raising the price of tobacco products and reducing their availability, in part by incentivising retailers not to sell them, might help tackle health inequalities.
NHS [National Health Service] Health Scotland and the Scottish Collaboration for Public Health Research and Policy (SCPHRP) at the University of Edinburgh have put forward these and other ideas as part of a new national tobacco strategy.
They want to see also mass media campaigns to encourage smokers to stop, and to reduce exposure to second-hand smoke.
They recommend that effective policy actions should focus on reducing health inequalities.
Twenty-one percent of adults in Scotland smoke, down from 28 percent in 2003.
However, adult smoking levels have been static since 2013.
And rates are still highest in the financially poorer areas of the country, with 35 percent of adults in the least well-off areas smoking compared to 10 percent in the most well-off areas.
Dr. Garth Reid, principal public health adviser at NHS Health Scotland and one of the study’s authors, said Scotland’s health was improving but that the gap between the health of the best and least well-off was widening.
NHS Scotland claims that smoking causes more than 10,000 deaths a year.
November 24, 2017
India wants an end to ENDS
India’s Union health ministry is planning to issue an advisory note to all states about what it sees as the health risks of vaping, according to a story on indianexpress.com.
The story said the note was likely to say that products such as ‘e-cigarettes, electronic nicotine-delivery systems (ENDS), nicotine and flavoured hookah’ were ‘extremely harmful to health’ and that they had not been approved in any form by the ministry of health and family welfare.
“The public will be advised, in their own interest, not to use any such products, sold or marketed in any form and under any name or brand,” a senior ministry official said.
But, according to a senior health ministry official, the health ministry is in a quandary over whether to ban e-cigarettes under the Cigarettes and Other Tobacco Products Act (COTPA), the Drugs and Cosmetics Act, 1940, or the Poisons Act 1919.
Some states, including Punjab, Chandigarh, Haryana, Kerala, Mizoram, Karnataka, and Jammu and Kashmir have already banned e-cigarettes as an unapproved drug. While some of these states have banned e-cigarettes under the Drugs and Cosmetics Act, some have used as well the Poisons Act.
And, just for good measure, the official said that nicotine had been declared a ‘lethal and hazardous’ substance under the Environment (Protection) Act and Insecticide Act.
In 2013, the Ministry of Health formed an expert group to assess and report on various forms of ENDs, which, in its final report in July said that scientific evidence clearly indicated that any form of nicotine use, or the use of ENDS, was hazardous. The group reportedly said, too, that, ‘besides, causing many forms of health disorders, nicotine is also classified as a poison and is fatal for human beings even in small dosage’.
Meanwhile, the Express reported that three sub-committees formed to examine the legal, advocacy and health aspects of e-cigarettes had strongly recommended a ban on them, stating that they had cancer-causing properties.
“Though companies claim that e-cigarettes help [smokers] give up smoking, but in reality they help initiate cigarette smoking as they deliver nicotine in an attractive way and attract youth,” the official said.
November 23, 2017
Smoking restrictions, no ban
Japan’s health ministry has relaxed its planned restrictions on tobacco smoking in restaurants, according to a story in the Japan Times quoting government sources yesterday.
The ministry, which initially planned to ban smoking in restaurants with a floor space of more than 30 square meters, is now leaning toward allowing smoking at restaurants with a floor space of up to 150 square meters.
The measure, expected to be implemented in time for the 2020 Tokyo Olympic and Paralympic Games, is likely to face criticism from doctors.
The ruling Liberal Democratic Party, some of whose members are said to have strong ties with the tobacco and restaurant industries, has argued that smoking should be permitted at restaurants with a floor space of up to 150 square meters.
It says that tougher smoking restrictions would deal a serious blow to some restaurants.
Under a new ministry proposal, even restaurants with a floor space of more than 150 square meters would be allowed to include special smoking rooms.
Smoking would be banned, however, in establishments that open after the implementation of the regulations and in those run by major restaurant chains.
Smoking would be banned also on the premises of clinics, hospitals, and elementary, junior-high and high schools.
According to World Health Organization standards, Japan is among the lowest ranked countries in tobacco control, with no smoke-free law covering all indoor public places.
November 17, 2017
Prices thrown into pot
If the price of legal marijuana must be competitive with black market marijuana to discourage underground sales, then the same logic should apply to nicotine products, according to a ctvnews.ca story quoting the head of Imperial Tobacco Canada.
Governments across Canada are preparing for marijuana’s legalization in 2018 and are creating legislative frameworks to regulate the industry. Bill Blair, the federal MP tasked with leading the drug’s legalization in Canada, has said the provinces generally agree that the price of legal marijuana should be roughly the same or lower than that of the marijuana that can be found on the street.
And Imperial’s Jorge Araya said that same rationale should apply to nicotine products.
Imperial wasn’t lobbying for lower taxes for traditional cigarettes but was against future increases as well as the federal government’s plan to require standardized packaging, he said.
Araya is lobbying also for a competitive tax regime for what he calls “less-risky” nicotine products, such as heat-not-burn products and electronic cigarettes, which, he says, represent the future of the industry.
“The first step is to stop tax increases provincially and federally because we are getting to a level where illegal tobacco is booming in the country,” Araya said in an interview after a speech organized by Quebec’s main employers’ association.
About 70 percent of the price of a pack of cigarettes was taxes, he said, and the illegal market in Canada represented 25 percent of sales and billions a year in lost revenue for governments.
“We will always advocate for very high taxation with (traditional) cigarettes,” he said. “We have to pay for the externalities and health impacts that we create – what we don’t want is to go higher than we are today,” he said.
Imperial Tobacco supports Bill S-5, which is making its way through the Senate and would legalize nicotine-containing vaping products in the country.
But Araya said the company was against the provision forcing companies to have standardized packaging for cigarettes because that would hinder the consumer’s ability to differentiate between products and with the black market.
Sindy Souffront, spokesperson for Health Canada, said in an email that vaping products, including e-cigarettes and e-liquids that contain nicotine, currently required authorization from Health Canada before they could be imported, advertised or sold in Canada.
“To date, no such products have been approved,” she said. “Under Bill S-5, manufacturers and importers of a vaping product containing nicotine would not be required to seek Health Canada approval, provided that the product does not make therapeutic health claims.”
Araya said that Imperial wanted to discuss nicotine products with the government and reach an agreement on how to treat taxation in a “very sustainable way”.
Meanwhile, a Quebec anti-tobacco coalition said it was misleading to treat tobacco like marijuana because tobacco, unlike pot, was tied to tens of thousands of deaths a year.
Flory Doucas, the group’s spokesperson, said “the goal of (Araya’s) speech was to rally the business community to the defence and interests of cigarette companies by stoking fear regarding new anti-tobacco measures and to publicize their new products.”
While Imperial Tobacco is lobbying the government on regulation, it is also waiting for a major court ruling that could force the company to pay hundreds of millions of dollars to smokers.
In 2015, a Quebec judge ordered three major cigarette companies, including Imperial Tobacco, to pay $15 billion to smokers as part of a class-action lawsuit.
The companies made arguments to the Quebec Court of Appeal about a year ago and are awaiting a decision.
Araya said his company isn’t ruling out going to the Supreme Court of Canada if it lost the appeal.
“Yeah, that’s one of the avenues, to go to the Supreme Court,” he said. “But at the moment that would be speculation. We are very confident about the strength of our arguments.”
November 14, 2017